Exhibit B Agency Program of Requirement POR.pdf

National Institutes of Health - Program of Requirements:

National Institute on Aging

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US Department of Health and Human Services National Institutes of Health

Program of Requirements for Replacement of NIH Off-Campus Leases Final Submission

3001 Hanover Street Baltimore, Maryland

Institute Center:

• National Institute on Aging

April 13, 2017

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TABLE OF CONTENTS

1. Executive Summary

2. Minimal Technical Requirements & Project Overview

2.1. Background

2.2. Objectives of the Program

2.3. Program Methodology

2.4. Facility Design Considerations

2.5. Space Definitions

2.5.1. Square Feet (SF)

2.5.2. Usable Square Feet (USF)

2.6. Defining Space Needs

3. Space Requirements

3.1. Space Program Development Criteria

3.2. Building Common Area

3.3. Circulation and Efficiency Factor

4. National Institute on Aging (NIA) Space Needs

4.1. National institute on Aging (NIA)

4.1.1. Mission, Activities and Organization

4.1.2. Program Considerations

4.1.3. Space Requirements, Work Flow Efficiencies and Adjacencies

5. Minimally Technical Requirements for the Spaces

5.1. General Design Standards

5.1.1. Design Criteria

5.1.2. Design and Planning Objectives

5.1.3. General Architectural Requirements

5.1.4. General Mechanical and Plumbing System Requirements

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5.1.5. General Electrical System Requirements

5.2. Office Space

5.2.1. Private Offices

5.2.2. Workstations

5.3. Support Space

5.3.1. Protocol Meeting Room

5.3.2. Conference Room – Reubins Andres

5.3.3. Reception Area

5.3.4. Participant Lounge (Day Room)

5.3.5. Equipment Storage

5.3.6. Medical Records

5.3.7. Staff Lounge

5.3.8. Coffee Bar

5.3.9. IT Office

5.3.10. Data Closets

5.3.11. Business Center

5.4. In Participant Areas

5.4.1. Private Participant Rooms

5.4.2. Semi-private Participant Rooms

5.4.3. Clamp Room

5.4.4. Nourishment

5.4.5. Housekeeping Closet

5.4.6. Nurse’s Station

5.4.7. Medication Room

5.4.8. Pharmacy with Clean Room

5.4.9. Clean Utility Room

5.4.10. Soiled Utility Room

5.5. Out Participant / Protocol Testing Areas

5.5.1. Exam Rooms

5.5.2. Procedure Rooms

5.5.3. Infusion Room

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5.5.4. Apheresis Room

5.5.5. Lab (Blood Processing)

5.5.6. Consult Room

5.5.7. Testing Rooms

5.5.8. Clean Utility

5.5.9. Toilet

5.6. MRI Suite

5.6.1. Waiting / Cognitive Testing

5.6.2. Toilet/Locker Room

5.6.3. Storage Closet

5.6.4. Control Room

5.6.5. Magnet Room

5.6.6. Equipment Room

6. Public Spaces

7. Building Common Amenities…

7.1. Loading …………………………………………………………………………………………………………………… 47

8. Parking……………

9. CIT Requirements

9.1.1. MDF……

9.1.2. LAN Closets

9.1.3. All Work Areas

10. ADA…………………………

11. Security………….……………………………………………………………………………………………………………… 50

12. Appendix……

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Appendix A: Model Plans

Appendix B: Space Data Sheets

Appendix C: Equipment Lists

Appendix D: NIH Design Requirements Manual (DRM) Chapter 11 Telecommunication

Amendment: NIH DRM Chapter 11

Appendix E: Pharmacy Requirement Design Guidelines

Appendix F: MRI Phillips Requirements

Appendix G: Sustainability Supplemental Information

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1. Executive Summary

The National Institutes of Health (NIH) currently leases office, medical clinics, research and MRI Lab space in an off-campus hospital facility. The space is occupied by NIH National Institute on Aging (NIA), Intramural Research Program (IRP), and houses approximately 85 employees, including vacancies. NIH is soliciting for a new 20-year with 15-year firm term.

The lease will also have NIH Provided Amenities which include shared space and services operated by the Center for Information Technology (CIT). A Main Distribution Frame space will feed LAN rooms common per floor and should meet the latest and upcoming NIH standards for telecommunications and interconnectivity. The NIH Division of Physical Security Management (DPSM) will assess the facility security level required by the federal standard and consult on the means to meet the federal requirements.

RMF Engineers, Inc. and Gaudreau, Inc., referred to as the Architectural Engineering (A/E) team have been retained by NIH to prepare this Program of Requirements (POR) to define space standards for the above-mentioned lease. This POR establishes the minimal technical requirements and provides information for the design and build-out specific to the unique and specialized operations of NIA within the lease. NIH’s Office of Research Facilities (ORF) has guided the A/E team in the POR development process and assisted in the methodology to assess the needs of NIA. The A/E team has collected data from interviews with key personnel from NIA, from visual observations of current space, and from reviews of existing plans and operations. A comprehension of the mission and ideology of NIA is the goal of this POR and integral to the planning of new NIA space. The POR outlines the projected needs for NIA in terms of medical clinic and support space. This POR, along with the Request for Lease Proposal (RLP), will be utilized for the acquisition of a replacement lease and then consequently used as the “basis of design” for the tenant fit-out design and construction of NIA leased area.

It is estimated that NIA will require approximately 26,000 Usable Square Feet (USF) (included circulation) to house the projected 85 employees and associated support spaces. This includes approximately 18,000 USF of medical clinic space, 3,000 USF of lab space, and about 5,000 USF of office space. Numbers are approximated accounting for vacancies and future growth projections.

NIA 26,000 USF / 85 Staff Medical Clinic Research Space 18,000 USF Lab Space 3,000 USF Office Space 5,000 USF

The procured facility shall be a state-of-the-art hospital building that meets governmental standards for sustainable facilities, including Energy Star Rating® and LEED for commercial interiors as stipulated in the RLP. Refer also to Appendix G for supplemental sustainability requirements. The

NIH Division of Facilities Planning Page 7 of 52 RMF Engineers, Inc. │ Gaudreau, Inc. Architects April 13, 2017 architectural and infrastructural characteristics of the building must enable NIA to meet its spatial, functional, operational and technical requirements as described in this POR in conjunction with the RLP. The building shall provide a robust integrated technology infrastructure that not only caters to NIA’s current requirements but also permits future changes, as NIA’s missions and functions evolve.

The offered space shall have convenient access to public transportation, and parking shall be available for all NIA staff / visiting participants and in compliance with applicable requirements of the local jurisdiction.

It is imperative that the offered space is located where code blue response is less than 5 minutes and the NIA physicians have privileges at an on-site hospital. Code blue is an emergency situation announcement in a hospital or institution in which a patient is in cardiopulmonary arrest, requiring a team of providers to rush to the specific location and begin immediate resuscitative efforts. NIA shall have access and use of the Hospital Registration System for participant registration, obtaining a Hospital ID number to allow access to full services provided by a CLIA-certified medical clinic laboratory. CLIA is a certification that ensures quality laboratory testing and whose results are accurate. The importance of this certification is that patient treatment is based on these results. If the lab is not certified, then Medicare and Medicaid will not pay for the testing.

The facility must provide separate service/delivery access from the primary entrance for employees and visitors. It shall be secured per standards outlined in The Interagency Security Committee (ISC) issued security standards for government leased space. Facility support for 24/7 emergencies must be provided for medical clinic space with overnight participants such as adequate mechanical, electrical and plumbing services.

The space offered must reflect the image of the NIA as a vital Federal agency. Its architecture and interiors shall be aesthetically appealing and use quality sustainable materials.

Projections for a 20-year lease create an opportunity for NIH to embrace a cultural change in the workplace. NIH encourages creative design alternatives to the current and traditional office models which will best support the mission of the NIA and the people who support that mission. The POR promotes flexibility for the evolution of the NIA workforce, and NIA has been tasked to define their individual preferences and needs in keeping with government mandated efficiencies. While challenging, the spirit of the changes are positive and inspirational and illustrate a movement towards a productive and healthful environment. The POR has embraced this opportunity to increase workflow efficiencies, enhance collaboration, and escalate overall morale of NIA.

2.0 Minimal Technical Requirements & Project Overview

Offeror’s proposal should meet the minimal technical requirements as further defined more specifically in Sections 4 and 5 and should incorporate all the requirements outlined in Appendix A “Model Plans”;

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Appendix B “Space Data Sheets; Appendix C “Equipment List”; Appendix D DRM Design Standards, CIT Construction Standards, Chapter 11; Appendix E Pharmacy Requirement Design Guidelines; Appendix F MRI Phillips Requirements; and Appendix G “Sustainability Supplemental Information”. In addition to meeting the minimal technical requirements of this POR, the Offeror must meet minimum technical requirements of the RLP.

2.1. Background

The National Institutes of Health (NIH) currently leases medical clinic and support space in an off-campus hospital facility for National Institute on Aging (NIA) with approximately 85 employees. The space also includes a Main Distribution Frame area operated by the Center for Information Technology

(CIT).

2.2. Objectives of the Program

The POR outlines the projected needs of NIA in terms of medical clinic, support space, and security requirements. The POR will:

• Inform the development community of NIH’s space and technical needs

• Provide information to ensure that the base building has the characteristics and capacity to meet the user’s needs, such as adequate mechanical, electrical, plumbing (MEP) services, data infrastructure, structural capacity and floor plates that are functional and efficient.

• Record the needs of the organization for integration with overall NIA space management.

The design period for Design Intent Drawings (DID) is anticipated to be about 160 working days and will require detailed communication between the stakeholders in developing the DID.

2.3. Program Methodology

The POR was developed from a review of the current situation and an assessment of planned future requirements.

• Interviews. Meetings were held with representatives from NIA onsite to review current space functions, to discuss strategies and concerns about reduced space allotments, and their expectations for operations and staffing for the next 20 years.

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• Space Review. The POR team reviewed the existing space of NIA to understand better specific needs and how the space is typically used. This was done by walking through the space and by reviewing specific needs of NIA.

2.4. Facility Design Considerations

NIH is a dynamic organization and expects that the new leased space will be flexible and supportive of efficient, integrated and collaborative endeavors. NIH will be seeking specific facility characteristics in addition to adequate square footage as described in the POR. Facility criteria include the following:

• Work Environment and Image. As an organization devoted to health and well-being, NIH requires its facilities to reflect this in interior environment and public image. The facilities should also provide visual interest and state-of-art features compatible with NIH’s mission of research and discovery. The building architecture should be a source of pride for employees and respect for the public, and the office space should promote comfort and productivity along with the health, safety, and well-being for the NIH personnel and research participants.

• Design Flexibility. The leased space must support a range of office, workstation, medical clinic research, and support space, to accommodate the patterns and requirements of NIA and its changes over time. The building should have a regular shape and spacing of the structural grid. The organization of the floors should support a generic concept that can be easily repeated and offer fluidity for some areas to grow while others contract, without major renovation. Adequate ceiling space shall be provided to maintain HVAC systems and to allow installation of future cabling. The design should also establish efficient and easily understood horizontal and vertical circulation that would not be affected by organizational changes.

• Layout Accommodations. Programs of Requirements have been based upon simple rectilinear floor plates consistent with Diagram 2.5.2a for USF with the minimum size of 26,000 sf. Buildings with configurations that are inconsistent with Diagram 2.5.2a for USF shall stipulate special lease considerations to fully accommodate the usable space requirements. As many of the NIA study participants are frail and elderly, NIA requires that the design of the medical clinic research space take into account the specific needs of the participants regarding accessibility of services and space design.

• Sustainable Design. Attention to sustainable design principles is important both for the comfort and well-being of personnel and the conservation of resources and government funds. The green goals and policies of the federal government and NIH encompass principles of energy conservation, intelligent building control systems, resource and

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2.5. Space Definitions

All space specifications included in the POR are defined as follows:

2.5.1 Square Feet (SF)

Where the acronym “SF” is shown, this represents the area associated with each individual room within the program.

2.5.2 Usable Square Feet (USF)

Usable Square Feet (USF), hereinafter referred to as “USF,” represents all space within the tenant area, inclusive of the square feet of the individual room under 2.5.1 above. It shall not include any common floor area such as floor common corridors, restrooms, janitor closets, LAN rooms, or elevator lobbies. See 2.5.2a Diagram for USF.

Diagram 2.5.2a for USF

2.6. Defining Space Needs

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The space requirements, for the purposes of this POR, have been classified as Medical Clinic Research Space, consisting of Research Office Space, Support Space, In Participant Areas, and Out Participant / Protocol Testing Areas. Within these categories, space has been allocated by NIA.

• Research Office Space, for the purposes of this program, includes the offices and workstations assigned to staff. NIA has assigned different office and workstation sizes to their various functions based on individual needs and functions.

• Support Spaces in this program are spaces within NIA which provide support to enhance the function of its mission. Support Spaces include reception areas, meeting rooms, filing rooms (including high-density filing), convenience print/copy/fax areas, equipment storage, data closets, IT office, kitchenette type space, and staff lounges. Support space requiring shell modifications include break rooms and copy rooms that require direct exhaust, high-density filing areas that require higher live load rated floors and data/LAN closets and IT storage areas that have special electrical and HVAC requirements. Many of the support spaces are distributed equitably, while others are allocated based on functional and operational needs.

• In Participant Areas in this program include participant rooms, nurse’s station, offices for medical clinic staff, USP 797 compliant pharmacy with clean room, utility and housekeeping closets, medication room and nourishment area. Space design should be suitable for frail, elderly participants. Allocation is based on function/work responsibilities. Specific requirements for the pharmacy can be found in Appendix E.

• Out Participant / Protocol Testing Areas in this program provide spaces that accommodate various medical clinic research testing and procedures, and lab space for NIA research. Out Participant / Protocol Testing Areas that may require shell modifications include the gait testing room which requires higher live load rated floor to accommodate the raised floor. Lab and medical clinic research space should meet applicable standards and requirements outlined in the National Institute of Health Design Requirements Manual (DRM). Allocation is based on function/research criteria and shall take into consideration the needs of an older population, with walkers, canes or wheelchairs, or other assistance devices.

• MRI Suite for this program are spaces that support the MRI magnet room which include a waiting area, toilet / locker room, storage, control room, magnet room and equipment room.

Allocation is based on function / research responsibility. Specific requirements for the magnet room and associated spaces can be found in Appendix F and should meet the standards and requirements outlined in the DRM. The MRI manufacturer should be consulted for the latest structural foundation requirements. MRI suite must be contiguous and accessible from within the hospital facility.

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3.0 Space Requirements

3.1 Space Program Development Criteria

Space allocation has been based on a combination of standard sizes and allowances as well as the specific mission and functional needs. A representative model plan has been provided to illustrate the unique requirements of each space and can be found in Appendix A and the Space Summary Sheet found in Section 4. Additional consideration should be given to the following:

A. Corridors: All public corridors within the NIA suite shall be protected with wall guardrails and corner guards. Corridors shall be sized as required for movement of medical clinic equipment but shall not be less than 5’ clear in ancillary public corridors and 8’ clear in the main public corridors exclusive of wall protection.

B. Scientific Equipment: Scientific equipment requirements listed in this POR shall be confirmed during the design development phase through consultation with NIA in order to account for new or replaced equipment items. Equipment planning should include documentation of both fixed equipment and NIA furnished medical clinic/lab equipment that requires floor space or special utility connections. Equipment documentation can be found in Appendix A: Model Plans and Appendix C: Equipment Lists.

3.2 Building Common Areas

Part of the Lessor’s rentable square footage shall include “Building Common Areas,” which refer to spaces that will be paid for by NIA; however, these will not be part of their area allocations. Specific requirements for the CIT spaces can be found in Appendix D.

A. Main Distribution Frame (MDF): MDF is the primary communication interface for NIH’s leased spaces with communication service providers as well as NIH’s overall network. The space is maintained and operated by the Center for Information Technology (CIT). This space will primarily contain standard communication equipment and UPS conforming to standards set by CIT. The MDF room should be located on the ground floor and should always be accessible to NIH CIT. The government has the right to bring in any utility to support the government entity at the leased site and the NIH mission for current and future pathways.

B. LAN rooms – LAN rooms must conform to the standards set by CIT. They should be centrally located with a maximum pathway from each room of 250 ft. radius. These rooms require separate HVAC and electric emergency back-up. These rooms shall be supported by 24/7 HVAC systems independent of the building’s main system and supported by on-site emergency generator power.

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3.3 Circulation and Efficiency Factor

For this POR, a circulation and efficiency factor has been added to the square footage for all the space types to derive the overall usable area as approved by ORF. The lessor’s project A/E shall endeavor to meet all of the requirements set forth in this POR, including the achievement of the most efficient design possible. It is anticipated that the design for various Institutes may render an efficiency rate better than the factor. Since NIA has been allocated a total usable area, this allocation shall be provided as set forth for each. During the DID process, the lessor’s project A/E will communicate with the NIH project manager (PM) for design direction and advise the NIH PM if any residual square footage is available for assignment. The NIH PM, upon receiving concurrence and/or approval from the NIA Scientific Director, will direct the Lessor’s A/E on how to apply the use of this space in the floor plan development.

The lessor’s A/E shall allow the NIH PM ample information on the available square footage and a minimum of two weeks for NIH to inform of alternative uses to be integrated for such areas (in the form of additional personnel, support or other areas). The design shall then be based upon the inclusion of such supplemental direction. This action shall be incorporated as though it was originally provided without a change in cost or time.

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4.0 National Institute on Aging Space Needs

The following sections provide mission, details of the space needs as well as the assumptions and bases for space allocation for NIA.

4.1 National Institute on Aging (NIA)

4.1.1 Mission, Activities, and Organization

The National Institute on Aging (NIA) is one of 27 Institutes and Centers that comprise the National Institutes of Health (NIH). NIA leads the federal government in conducting and supporting research on aging and the health and well-being of older people. The Institute seeks to understand the nature of aging and the aging process, and diseases and conditions associated with growing older, in order to extend the healthy, active years of life.

In 1974, Congress granted authority to form NIA to provide leadership in aging research, training, health information dissemination, and other programs relevant to aging and older people. Subsequent amendments to this legislation designated NIA as the primary Federal agency on Alzheimer’s disease research.

The Institute’s mission is to:

• Support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging.

• Foster the development of research and clinician scientists in aging.

• Provide research resources.

• Disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences.

NIA sponsors research on aging through extramural and intramural programs. The extramural program funds research and training at universities, hospitals, medical centers, and other public and private organizations nationwide. The intramural program conducts basic and clinical research in Baltimore, MD and on the NIH campus in Bethesda, MD. This POR is associated with the intramural program in Baltimore, MD.

The Intramural Research Program (IRP) in the NIA is comprised of nine scientific laboratories, the

Translational Gerontology Branch, and ten core facilities. The research program has three main focus areas: Neuroscience, Aging Biology, and Translational Gerontology. IRP scientists conduct research in many different disciplines that range from basic science to clinical research and epidemiology. Medical problems, which typically affect older persons, are studied in depth using the tools of medical clinical research, with a translational perspective. The central focus of our research is understanding age-related changes in physiology and the ability to adapt to environmental stress. This understanding is then applied to

NIH Division of Facilities Planning Page 15 of 52 RMF Engineers, Inc. │ Gaudreau, Inc. Architects April 13, 2017 developing insight about the pathophysiology of age-related diseases. In addition to studying the common age-related diseases, such as Alzheimer’s disease, Parkinson’s disease, stroke, atherosclerosis, osteoarthritis, diabetes and cancer, we also explore the determinants of healthy aging as possible targets for interventions aimed at improving health and quality of life in the older population at large.

IRP research is conducted in multiple sites; most of the basic science laboratories are located at the

Biomedical Research Center on the Johns Hopkins Bayview Campus in Baltimore, MD. The Medical Clinic

Research Core is located at Harbor Hospital, a few miles south of the Bayview Campus in Baltimore, MD.

The NIA Medical Clinic Research Core at Harbor Hospital is also home of the Baltimore Longitudinal Study of Aging, a longitudinal study of aging that was started as far back in time as 1958. The Laboratory of

Neurogenetics is located on the NIH main campus in Bethesda, and the Laboratory of Epidemiology and

Population Science is co-located in the Gateway Building in Bethesda and the Biomedical Research Center in Baltimore. Finally, the Healthy Aging in Neighborhoods of Diversity across the Life Span study

(HANDLS), a longitudinal study that addresses health disparities associated with race and socio-economic status, is profoundly rooted in several Baltimore neighborhoods.

The IRP provides a stimulating academic setting that encourages and fosters a comprehensive effort to understand aging through multidisciplinary investigator-initiated research. Particular emphasis is put on the value of synergistic interaction and collaboration through inter-laboratory collaboration. The program offers many excellent training opportunities in both medical clinic and support laboratory and medical clinic medicine with a wealth of valuable resources. The NIA is committed to training researchers for lifetime careers in the biomedical and behavioral science.

NIA - Office of the Director - Intramural Research Program (IRP)

Laboratory of Cardiovascular Science

Laboratory of Molecular Biology and Immunology

Laboratory of Clinical Investigation

Laboratory of Epidemiology and Population Science

Translational Gerontology Branch

Laboratory of Genetics

Laboratory of Molecular Gerontology

Laboratory of Neurogenetics

Laboratory of Behavioral Neuroscience

Laboratory of Neurosciences

Comparative Medicine Section

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4.1.2 Program Considerations

The NIA medical clinic research program consists of 85 staff members, made up of full-time employees and contract personnel. The composition of the NIA program consists of approximately 69% medical clinic research space, 19% office space and 12% for lab space. NIA requires controlled access 24/7 to the space, such as card-key/other restricting access to create a "government enclave" with access to NIA staff. Within the NIA space, there will be other areas where access is limited to a very small restricted group as determined by NIA Clinical Director.

A. Office Space: The NIA offices are located throughout the space with a distinct research area made up of only private offices and workstations. This research area includes the Office of the Clinical Director suite and the BLSA suite. Other private offices are located throughout the in participant and out participant/protocol testing areas depending on their association with various medical clinic research functions and activities. Space planning concepts for NIA should be driven to reflect a long-term goal for growth and flexibility. The design vision should recognize that change is constant. Private offices shall have appropriate sound abatement with full-height partitions extending to the underside of the slab above and sound dampeners at partitions with air vents. The Office of the Clinical Director’s suite should be entered through a secure entry. The protocol meeting room should be located directly off the entry with the Clinical Director’s office nearby. Private offices and workstations along with a business center make up the remainder of the suite. The BLSA suite should include a central area with work station and private offices along the exterior of the suite.

B. Support Space: Visitors to the suite shall enter through secure doors into a Reception Area with receptionist who will direct the flow of traffic. The reception area should have direct access to the conference room and an adjacent coffee bar. A waiting area should be located next to the reception desk and have direct access to in participant and out participant areas. A participant lounge (day room) should be located in a private area adjacent to the participant overnight rooms. This room should be enclosed to provide privacy. One staff lounge should be located near the nurse’s station and include lockers.

The second staff lounge should be located near the research office area and include some general storage. These rooms should promote casual interaction and socializations, making use of any residual areas for casual seating and exchanges. NIA Data closets and LAN closets should be uniformly distributed throughout the space or as required by specific functionality.

C. In Participant Areas: Private and semi-private rooms make up the large portion of this area. These rooms should be located in a quiet, discreet area away from the general public; secured by card key/ID access controlled by NIA. The nurse’s station should be

NIH Division of Facilities Planning Page 17 of 52 RMF Engineers, Inc. │ Gaudreau, Inc. Architects April 13, 2017 centrally located within the private/semi-private room area along with the nourishment niche and medication room. The clamp room, clean and soiled utilities, and housekeeping closet should be located adjacent to the nurse’s station. Other spaces that should be located near the nurse’s station include the pharmacy, nurse manager with assistant office, team lead offices, nurse practitioner office, office currently located in the reception area and the recruiter’s office.

D. Out Participant Areas: Various testing rooms including the infusion and apheresis room are located in this designated area. Consultation rooms should be located adjacent to the reception area with exam rooms next to these rooms. The psych testing rooms and echo doppler testing rooms should be located adjacent to their associated workstations.

E. MRI Suite: The MRI suite is preferably located in the lowest level of the leased building and shall not be located near a loading dock. The magnet room floor should be a slab-on-grade slab over drained soiled and isolated from the surrounding floor slab. Areas above this space may be subject to access restrictions and strict vibration criteria. This suite requires direct access to the exterior. Ambient vibration must be at a low level as designated in the plans provided in Appendix F.

F. Pharmacy with Ante Room and Clean Room: The design of the pharmacy requires the full understanding of the Process and Infrastructure elements in order to achieve a facility that is fully compliant with the current USP 797. The Process element looks at the compounding process and operations and equipment required to carry out the sequence of steps required to produce the product. The Infrastructure includes the policies, procedures, and practices used to operate the Process within the pharmacy.

Prior to the detailed design of the pharmacy, a cGMP consultant shall be retained to interpret the appropriate USP 797 requirements and provide guidance to ensure USP 797 compliance to meet the unique needs of NIA. The cGMP consultant team should include a Ph.D./process engineer, regulatory compliance engineers and architect SME’s who have demonstrated at least 10 years of experience with USP 797, cGMP facilities and similar pharmacy facilities. The following defines the cGMP consultant scope of work:

1. Develop Process Flow Diagrams that define the DCA (Direct Control Area) and PEC

(Process Engineering Control). Write/find appropriate procedures that define the movement and control of material before, during, and after compounding and to ensure there are no mix-ups or cross-contamination.

2. Review of the written QA program including characteristics described in USP 797.

3. Review policies and procedures for the direct supervision and control of compounding and dispensing of CSP’s.

4. Review of procedures and documents required for trending and maintaining batch records.

5. Review of training and evaluation procedures, and maintenance of training records.

6. Review of garbing and aseptic work practices; surface cleansing and disinfection

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7. Provide a preliminary layout of the facility.

8. Review of particulate monitoring systems and the engineering and environmental monitoring control system.

9. Define temperature, humidity, filtration, air changes per hour, pressurization, unidirectional airflow requirements.

10. Define redundancy, segregated HVAC systems, single pass air vs. recirculated

HVAC systems, and the utility requirements for the Pharmacy.

11. Define emergency power requirements for HVAC, PEC’s and other equipment serving the Pharmacy.

12. Define requirements for BAS (Building Automation System) control systems, including alarms, response, security, storage, historian capabilities.

13. Define all architectural and lighting and electrical features so surfaces can be sanitized, cleaned, lighting fixtures are sealed and gasketed, all penetrations are sealed, and appropriate placement of PEC’s so they are placed out of traffic and disruption from HVAC.

14. Review of the purity water systems required for manufacture and cleaning.

15. Define requirements for in situ static and dynamic smoke studies, air velocity to prevent turbulence and air stagnation in the critical area.

16. Review of pass through equipment including refrigerators between anteroom and buffer room to reduce any risk of contamination.

17. Review of all Maintenance procedures, including testing frequency, shutdown procedures to operate and maintain the facility in the state of control.

18. Review of the Change control procedures.

19. Reviews facility commissioning and equipment qualification requirements.

20. Review impact of proposed USP 797 that is currently under revision and the draft is out for review. It is likely that this revision may be released prior to the operation of the facility.

G. Special Areas Provisions: The entire NIA Medical Clinic Unit will have restricted access (not open to the public; requiring ID access). In addition, the following areas are further restricted to designated staff only: the pharmacy, IT Office, IT storage room, the procedure room, medical record room, clean utility, medication room, 3T MRI Suite, and the Office of the Clinical Director Suite. These areas will have secure card access which will require special wiring as outlined in Section 5. The floor slab under the HD filing system and the gait room raised flooring will require the enhanced structure to accommodate the weight of these systems. The MRI suite requires special magnetic shielding around the magnet room along with a separate HVAC system and UPS for the magnet room, control room, and equipment room. The equipment room requires a raised floor.

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4.1.3 Space Requirements, Work Flow Efficiencies, and Adjacencies

Institute Center: National Institute on Aging

Space Type Designation Plan/ Data

Staff Quantity

Proposed

(SF)

Room Quantity

Total Proposed Area

Research Office Space Office A Clinical Director A1/1 1 210 1 210

Office B Supervisory Med.Officer (BLSA) /3T MRI Staff Scientist /Office Manager

A2/1a 3 120 3 360

Workstation A

FTE Support Staff / FTE Testers / Contractors (includg Testers, Nurses, BLSA Suite Coord) / Fellows

B1/1b 25 30 25 750

Workstation B FTEs ( Research Fellow) B1/1b 1 48 1 48

Workstation C

FTE Support Staff (including 3 MDs, 1 Ph.D., Protocol Office Lead, Prot Coord, IT Lead, Statistician)

B1/1b 9 64 9 576

Floating / Shared Workstation D Special Volunteers / PRNs / Part-Time Staff / Courier (Contr)

B1/1b 8 30 8 240

Subtotal: Personnel Space 2184

Support Space Protocol Meeting Room (NM537) 8-12 people C1/1c 0 252 1 252 Conference Room - Reubin Andres (NM501) 30 people C2/1d 0 540 1 540 AV Closet (Lg Conf room NM501) C2/1d 30 1 30 Reception Area-Front Desk / Waiting Room (CM501) C3/1e 1 370 1 370

Reception Area Office (CM503) C3/1a 3 120 1 120 Participant Lounge (Day Room) (CM505) C4/1f 0 280 1 280 Equipment storage (SM518) C5/1g 0 190 1 190 Medical Records (Secure HD Files) (SM500) C6/1h 1 350 1 350 Staff Lounge (SM525) C7/1i 0 180 1 180 Staff Lounge / Storage (NM520) C8/1j 0 140 1 140 Coffee Bar C9/1k 0 60 1 60 IT Office (NM523) C10/1m 2 220 1 220 NIA Data Closets C11/1n 0 80 2 160 LAN Closet(SM521, SM502A) C11/1n 0 80 2 160 Business Center (NM535) C12/1o 0 300 1 300 Lactation Room C13/1p 0 80 1 80 Data Center (Basement) 0 84 1 84

Subtotal: Support Space 3516

Medical Clinic In Participant Areas Private Participant Rooms (SM529, SM531, SM534,SM537, SM539) D1/2 0 270 5 1350

Semi-private Participant Room (SM532) D2/2a 0 500 3 1500 Semi-private Participant Room (SM528) D3/2a 0 270 1 270

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Clamp Room (SM530) D4/2b 1 500 1 500 Nourishment ( Sth Corridor) D5/2c 0 35 1 35 Housekeeping Closet (SM516, SM502B) D5/2d 0 40 2 80 Team Leads' Offices (SM523A) D6/2e 2 200 1 200 Supervisory Nurse Specialist Office A2/1a 1 30 1 30 IT Support Assistant (Next to Supv Nurse Spec) (SM517) D7/1b 1 30 1 30

Nurses Station (SM533) D8/2f 7 200 1 200 Medication Room (SM535) D8/2g 0 50 1 50 Nurse Practitioners' Office (SM522) D9/2h 2 128 1 128 Nurse Practitioner File (SM522) D9/2h 0 80 1 80 Recruiter's Office (SM526) D10/2h 1 128 1 128 Recruiter Office File (SM526) D10/2h 0 80 1 80 Pharmacy w/ clean room (SM527) D11/2i 2 500 1 500 Pharmacy Cleaning Closet D11/2d 0 40 1 40 Clean Utility (locked rm - SM514) D12/2j 0 190 1 190 Soiled Utility (SM520) D12/2k 0 70 1 70

Subtotal: In Participant Areas 5461

Medical Clinic Out Participant /Protocol Testing Exam Rooms E1/2m 0 130 5 650 Procedure Rooms (SM524) E2/2n 0 400 1 400 Infusion Room (SM505) E3/2o 3 800 1 800 Apheresis Room (SM501) E4/2p 2 740 1 740 Lab (blood sample processing) n(SM504) E5/2q 0 200 1 200 Consult Room (SM511) E6/2r 0 100 2 200 Vision & Tongue Testing (SM506 , SM508) E6/2s 0 100 2 200 Testing Rooms (psych NM504, NM507,NM505) E7/2t 110 3 330

Testing Work Room (NM 503) E8/2u 4 200 1 200

Testing Room (Doppler NM511, NM509) E9/2v 1 100 2 200 Testing Storage (NM503B, NM513) E10/2w 90 2 180 Tech Work (NM514) E11/2u 0 250 1 250 Treadmill (NM512) E11/2x 0 175 1 175 Strength (NM518) E12/2y 0 170 1 170 DEXA (NM516) E13/2z 0 140 1 140 VEMP testing (NM506) E14/2t 0 110 1 110 General Storage (Observation NM508) E15/2aa 0 230 1 230 Gait testing (NM500) E16/2bb 0 390 1 390 *** 400-meter hallway walk 0 1 Clean Utility (NM510) (ice machine, storage) E17/2j 0 200 1 200 Toilet 0 40 2 80

Subtotal: Out Participant /Protocol Testing Areas 5845

Subtotal Personnel 81

Subtotal Research, Support, In Participant, and Out Participant Space SF 17006 Current Circulation and Efficiency Factor @ .70 0.70 Subtotal Usable Square Feet (USF) 24294

Medical Clinic MRI Suite 3T MRI Suite

Waiting Room E18/3 150 1 150

Toilet Room E18/ 3a

80 1 80

Locker Room

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Storage E18/ 3b 35 1 35 Control Room E18/ 3c 4 350 1 350 Magnet Room E18/ 3d 490 1 490 Corridor E18/ 3e 157 1 157 Equipment Room E18/ 3f 390 1 390

Subtotal: MRI Area 1652

Total Personnel 85

Summary of Program Areas

Total Usable Square Feet (USF) including the MRI Area 25,946

See Appendix A- Model Plans See Appendix B- Space Data Sheets See Appendix C - NIA Equipment List

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Work Flow Efficiencies and Adjacencies

Diagrammatic Plan

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For further clarification refer to study plan in Appendix A.

National Istitute on Aging

Institute Guideline:

Adjacency Priority

Cl in ica l D ire ct or S ui te a nd

B

LS

A Di re ct or S ui te

(s ep ar at e bu t n ea r)

O

CD

S ta ff, P ro to co l O ffi ce

, B us in es s C en te r

Ph ys ici an s a nd

R es ea rc he rs

IT

st af f

Fr on t D es k Re ce pt io n, C of fe e

Ba r, W ai tin g

Ro om

, D ay

R oo m

M ed ica l R ec or ds w ei gh t b ea rin g)

Ec ho

, D op pl er

, T re ad m ill , D ex a

Te st in g

Te st in g:

V isi on , P ro pr io ce pt io n, E

M G, T on gu e, V

EM

P

Te st er s

Ps yc h Te st in g

Ap he re sis

, I nf us io n

RM

, C la m p, P ro ce du re R oo m

, U til ity R oo m s

N ur se M an ag er , T ea m

L ea ds /C

RC

, N ur se

P ra ct iti on er s, Re cr ui te r a nd E xa m

R oo m s

Ph ar m ac y

N ur se s S ta tio n, P ar tic ip an t R oo m s, N ut rit io n Ce nt er

St af f L ou ng e

(s

3T M

RI

Clinical Director Office and BLSA Director Office (separate but near) NA 1 2 4 2 4 4 4 4 4 2 2 2 2 2 4

OCD Staff, Protocol Office, Business Center NA 2 4 2 4 NA NA NA NA NA 2 4 4 2 4

Physicians and Researchers NA 4 3 3 2 4 4 4 2 2 4 4 2 2

IT Staff NA 4 NA 4 4 NA NA NA 4 4 NA 2 4

Front Desk Reception, Coffee Bar, Waiting Room, Day Room NA 1 2 2 2 2 2 1 2 2 2 2

Medical Records (weight bearing) NA NA NA NA NA 1 1 NA 1 NA NA

Echo, Doppler, Treadmill, Dexa Testing NA 1 1 NA NA 2 NA 2 NA NA

Testing: Vision, Proprioception, EMG, Tongue, VEMP NA 1 NA NA 2 NA 2 NA NA

Testers NA NA NA 2 NA 2 2 NA

Psych Testing NA NA 2 NA 2 2 2

Apheresis, Infusion RM, Clamp, Procedure Room, Utility Rooms NA 1 2 2 2 2

Nurse Man, Team Leads/CRC, Nurse Practitioners, Recruiter and Exam Rooms NA 2 2 2 2

Pharmacy NA 2 2 4

Nurses Station, Participant Rooms, Nutrition Center NA 2 2

Staff Lounge (s) NA NA

3T MRI NA

The red numbers are for illustration. Please delete and fill in as appropriate.

Requires Close Proximity for Hourly Interaction 1 Requires Close Proximity for Daily Interaction 2 Requires Proximity for Occassional Interaction 3 Proximity Convenience for Periodic Meetings 4 Proximity Does Not Matter NA

List each of the functional working group within the institute along the side column and across the top row (in place of Office No. 1, etc.). Add rows and columns if required. Then place a number in the chart that corresponds to the approximate physical adjacency between each department for space planning purposes. See the legend below.

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5.0 Minimally Technical Requirements for the Spaces

5.1 General Design Standards

The RLP lists the majority of the technical requirements for the spaces including but not limited to general architectural requirements, architectural finishes, mechanical, electrical and plumbing requirements, fire protection, life safety, security and environmental issues. The technical requirements stated in this POR are above and beyond those stated in the RLP.

The following general regulations and design standards shall apply. In the event of any conflicts of the RLP, the contracting officer shall make a determination on which requirement shall prevail.

A. Applicable Federal Regulations: The design and contract documents shall be in accordance with all applicable Federal Regulations including but not necessarily limited to the following:

Architectural Barriers Act, OSHA 29CFR 1910.

B. Applicable Departmental Regulations: The preparation of the design and contract documents shall be in accordance with the Volume I and Volume II of the HHS Facilities Program Manual.

C. Applicable Agency Regulations: The design and contract documents shall be prepared in accordance with the NIH Design Requirements Manual, NIH Office Fit-out Standards, and GSA Facilities Standards for Public Buildings.

D. Applicable Local Code Regulations: The design and contract documents shall be prepared in accordance with the applicable standards of the local building code where applicable, International Building Code, National Fire Protection Association (NFPA) such as the Life Safety Code (NFPA 101) and Standard for the Installation of Sprinkler Systems (NFPA 13).

E. Utility Company Regulations: Local Utility company regulations must be followed.

F. Industry Standards: The following industry standards are used as references: American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE), "Quality Standard for Instrument Air" as published by the Instrument Society of America (ISA), American National Standards Institute (ANSI) A17.1, USP 797, USP 795 (Nonsterile Compounding), FDA cGMP Guidelines for Investigational Drugs, Guidelines for the for Design & Construction of Healthcare Facilities and National Electric Code (NEC). USP Standards and Guidelines can be found at http://www.usp.org.

http://www.usp.org/

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5.1.1 Design Criteria

This Program of Requirements focuses on general planning requirements. Technical and engineering requirements listed herein are intended to supplement the National Institutes of Health Design Requirements Manual (DRM) in areas that may require program or site-specific interpretation. Variances listed in the DRM Appendix for off-campus leased facilities shall apply. The facility shall also meet code requirements of the jurisdiction having authority. Because certain DRM requirements are not applicable to lease facilities, the NIH Lease Facilities Design Requirements Manual Checklist shall be utilized throughout project design and construction to verify that project teams correctly apply the DRM to leased facilities.

The NIH Design Requirements identify a waiver process to be used in cases where specific requirements cannot be met or are not applicable. The Government reserves the right to accept or reject such waivers based on program, technical, cost, and safety considerations. Inconsistencies and questions of Design Requirements applicability shall be referred to the NIH Project Officer (PO) for resolution.

5.1.2 Design and Planning Objectives

The design must meet several basic objectives that are driven by functional requirements of the research. Key objectives include the following:

• Provide workplace that is designed for science administration of the next decade

• Provide spaces which encourage employees to engage in informal collaboration within the workplace to promote the advancement of science.

• Provide people with access and proximity to resources they need

• Provide a comfortable, inviting work environment with abundant natural light and improved amenities for employees

• Embrace accessibility for people of all types of ability and provide a truly accessible workplace through the use of Universal Design

• Meet space and adjacency requirements

• Maximize efficiency of space use

• Minimize renovation costs by utilizing existing building infrastructure where compliant with NIH

Requirements, and retaining elements of the existing construction that are in good condition and suitable for inclusion in the modified space.

• Provide a variety/sufficient number of meeting spaces with current technology to support conferencing as well as sufficient spaces for quiet, concentrative work

The leadership of NIA shall be interviewed (prior to the start of design) to clarify and update the distribution and allocation of research office space, support space, in participant areas, out participant areas, and MRI suite associated within NIA’s facility as set forth in Section 4: National

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Institute on Aging Space Needs. This data will form the space organizational strategies.